Technician, Bio Process Operations
- Execute manufacturing operations, environmental monitoring, and facility disinfection
- Set up and operate vaccines formulation, aseptic primary filling, inspection, packaging, CIP/SIP, and additional equipment within qualified parameters
- Identify potential equipment problems and partner with Vaccines Maintenance Technicians to ensure appropriate resolution. Demonstrate ability to troubleshoot process, electronic systems, and equipment for routine and basic problems.
- Perform other duties as requested by the Operations coach
- Accountable for performing work in a safe manner, following identified safety procedures (hazardous work permitting, LOTO, HECPs), and using applicable safety equipment / personnel protective equipment (PPE)
- Execute operations functions in accordance with current Good Manufacturing Practices (cGMPs) and standard operating procedures (SOPs)
- Complete documentation in batch records, electronic logs, or other systems in accordance with site procedure
- Maintain good housekeeping and 5S in assigned work area
- Adhere to the highest level of data integrity while performing duties
- Identify potential quality or safety issues.- Escalate as per IPT management processes and assist in the investigation, root cause determination, and CAPA implementation.
- Ensure that startup activities for area of assignment are executed such that project deliverables and timelines are met
- Closely monitor team / process performance and improve reliability through problem solving and continuous improvement
- Set up and operate equipment in alignment with established training and procedures to ensure reliable operation with minimal delays or discards
- Identify and help implement continuous improvement and productivity enhancements within the IPT
- Partner with Technicians and cross-functional groups for assigned area
- Demonstrate a high degree of maturity and personal integrity.- Strictly adhere to all site policies on personal conduct and attendance.-
- Train, develop, and mentor other team members to share experience and best practices
- Pursue knowledge and skills in assigned area from an operations perspective and share that information readily with team
- Maintain a culture of continuous improvement / MPS focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving
- Routinely demonstrates leadership and conflict-resolution ability.- Demonstrates a willingness to provide and receive constructive feedback in 360° performance review.
- Solid line report to: Manager, Maintenance & Operations--------
- Dotted line report to: N/A
- Position(s) reporting to this position: N/A (individual contributor)
- 8-hours, 2nd shift
- High School diploma or equivalent-
- Three or more years of experience in a GMP manufacturing facility (aseptic GMP environment strongly preferred).-
- Demonstrated ability to work independently and as team member
- Demonstrated interpersonal skills with ability to influence and assist others through a culture of inclusion, feedback, and empowerment
- Ability to gown and work in an aseptic environment
- Demonstrated ability to work with computerized and automated systems.
- Willing to work irregular hours to support multi-shift operation on an as needed basis
- Associates degree in Business, Science, or Technology-based field and/or bio-pharma focused certificates such as Bioworks preferred.
- Experience with aseptic filling, visual inspection systems, CIP/SIP systems, packaging equipment and similar aseptic formulation and filling operations
- Experience operating, maintaining, troubleshooting, and/or repairing industrial equipment
- Experience working in a regulated environment (FDA, etc.) and basic knowledge of cGMPs as they apply to the vaccine/pharmaceutical industry
- Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies
- SAP / MES / electronic logbook basic knowledge from a production execution perspective
- Demonstrated leadership ability, peer training experience, and/or productivity improvement activities
- Demonstrated ability and drive to work autonomously and help organize priorities and work with other team members
- Outstanding communication skills both within direct team and across multiple shifts to ensure success of overall team
- Ability to support technical writing of documents such as standard operating procedures (SOPs)
Accountability, Accountability, Analytical Problem Solving, Batch Record Review, Biological Manufacturing, Cleanroom Gowning, Computer Literacy, Data Integrity, Environmental Monitoring, Global Manufacturing, GMP Compliance, GMP Operations, Good Manufacturing Practices (GMP), Healthcare Innovation, Industrial Maintenance, Laboratory Processes, Lean Manufacturing, Lean Product Development, Machinery Operation, Machine Troubleshooting, Manufacturing, Manufacturing Quality Control, Operations Support, Packaging Operations, Pharmaceutical Manufacturing {+ 5 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement• We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". San Francisco Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: -We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully-
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.- Employee Status:
Regular Relocation:
No relocation VISA Sponsorship:
No Travel Requirements:
No Travel Required Flexible Work Arrangements:
Not Applicable Shift:
2nd - Evening Valid Driving License:
No Hazardous Material(s):
na Job Posting End Date:
02/25/2026
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R382929
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